Combination Chemotherapy Plus Radiation Therapy With or Without Fluorouracil in Treating Patients With Cancer of the Esophagus or Stomach - Full Text View

Sponsor:	Radiation Therapy Oncology Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00009880

Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy and radiation therapy may kill more tumor cells.

PURPOSE: Randomized phase II trial to compare the effectiveness of combination chemotherapy plus radiation therapy with and without fluorouracil in treating patients who have cancer of the esophagus or stomach.

Condition	Intervention	Phase
Esophageal Cancer Gastric Cancer	Biological: filgrastim Drug: cisplatin Drug: fluorouracil Drug: paclitaxel Radiation: radiation therapy	Phase II

Study Type:	Interventional
Study Design:	Treatment
Official Title:	Non-Operative Therapy Of Local-Regional Carcinoma Of The Esophagus: A Randomizd Phase II Study Of Two Paclitaxel-Based Chemoradiotherapy Regimens

Resource links provided by NLM:

MedlinePlus related topics: Cancer Esophageal Cancer Esophagus Disorders Stomach Cancer

Drug Information available for: Fluorouracil Cisplatin Paclitaxel Filgrastim

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

April 2001

Detailed Description:

OBJECTIVES:

Compare the survival and failure patterns in patients with previously untreated carcinoma of the esophagus or gastroesophageal junction treated with cisplatin, paclitaxel, and concurrent radiotherapy with or without fluorouracil.
Compare the tolerance of these regimens by these patients.
Compare the overall quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to percentage of weight loss (less than 10% vs 10% or more), disease histology (adenocarcinoma vs squamous cell carcinoma), and lesion size (no more than 5 cm vs more than 5 cm). Patients are randomized to one of two treatment arms.

Arm I: Patients receive induction chemotherapy comprising fluorouracil IV continuously over 24 hours and cisplatin IV over 1 hour on days 1-5, paclitaxel IV continuously over 24 hours on day 1, and filgrastim (G-CSF) subcutaneously daily on days 6-15. Treatment repeats every 4 weeks for up to 2 courses. Patients with stable or responsive disease after the first course of induction therapy receive a second course of therapy. Patients with local disease progression after the first course proceed to chemoradiotherapy.

Beginning on day 29 of the last course of induction chemotherapy, patients undergo radiotherapy 5 days a week for 5.5 weeks. Patients also receive fluorouracil IV continuously over 24 hours on days 1-5, 8-12, 15-19, 22-26, and 29-33, and paclitaxel IV over 3 hours on days 1, 8, 15, 22, and 29.

Arm II: Patients receive induction chemotherapy comprising cisplatin IV and paclitaxel IV over 3 hours on day 1. Treatment continues every 3 weeks for 2 courses as in arm I.

Beginning on day 29 of the last course of induction chemotherapy, patients undergo radiotherapy as in arm I. Patients also receive cisplatin IV on days 1, 8, 15, 22, 29, and 36, and paclitaxel IV continuously over 96 hours on days 1-4, 8-11, 15-18, 22-25, 29-32, and 36-39.

Quality of life is assessed at baseline, within 1 week after radiotherapy, at 6 weeks after study completion, every 4 months for 1 year, every 6 months for 2 years, and then annually for 5 years.

Patients are followed within 8 weeks, every 4 months for 1 year, every 6 months for two years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 84 patients (42 per treatment arm) will be accrued for this study within 21 months.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed primary squamous cell carcinoma or adenocarcinoma of the esophagus or gastroesophageal junction
- Stage I-III (T1, N1, M0; T2-4, N any, M0)
  - Supraclavicular or celiac lymph node involvement allowed
Disease entirely confined to the esophagus or gastroesophageal junction and peri-esophageal soft tissue
Cervical esophageal carcinoma allowed
No tumor extension beyond 2 cm into stomach
No multiple primary carcinomas of the esophagus
No evidence of disseminated cancer
No tracheoesophageal fistula or direct invasion into the mucosa of the trachea or major bronchi
- Bronchoscopy with biopsy and cytology required if the primary carcinoma is less than 26 cm from the incisors or is at or above the carina by imaging study

PATIENT CHARACTERISTICS:

Age:

Not specified

Performance status:

Zubrod 0-1

Life expectancy:

Not specified

Hematopoietic:

Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 150,000/mm^3
Hemoglobin at least 10 g/dL

Hepatic:

Not specified

Renal:

Creatinine no greater than 1.5 mg/dL
Creatinine clearance at least 65 mL/min

Cardiovascular:

No uncontrolled heart disease
No uncontrolled hypertension

Other:

Total oral/enteral intake must be at least 1,700 kCal/day
Not pregnant or nursing
Fertile patients must use effective contraception
No uncontrolled diabetes
No other malignancy within the past 5 years except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Not specified

Chemotherapy:

No prior systemic chemotherapy
No other concurrent chemotherapy

Endocrine therapy:

Not specified

Radiotherapy:

No prior chest radiotherapy

Surgery:

No prior major esophageal surgery

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00009880

Hide Study Locations

Locations

United States, Alabama
Mobile Infirmary Medical Center
Mobile, Alabama, United States, 36652-2144
United States, Arizona
Foundation for Cancer Research and Education
Phoenix, Arizona, United States, 85013
United States, California
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
Leavey Cancer Center at Northridge Hospital Medical Center
Northridge, California, United States, 91328
United States, Florida
Baptist-South Miami Regional Cancer Program
Miami, Florida, United States, 33176-2197
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
University of Florida Shands Cancer Center
Gainesville, Florida, United States, 32610-0385
United States, Hawaii
Cancer Research Center of Hawaii
Honolulu, Hawaii, United States, 96813
United States, Illinois
Methodist Medical Center of Illinois
Peoria, Illinois, United States, 61636
United States, Indiana
Cancer Center at Ball Memorial Hospital
Muncie, Indiana, United States, 47303-3499
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202-5289
Memorial Hospital of South Bend
South Bend, Indiana, United States, 46601
Union Hospital
Terre Haute, Indiana, United States, 47804
Veterans Affairs Medical Center - Indianapolis (Roudebush)
Indianapolis, Indiana, United States, 46202
United States, Iowa
Wendt Regional Cancer Center at Finley Hospital
Dubuque, Iowa, United States, 52001
United States, Kentucky
Esther Marie Hatton Cancer Care Center at St. Elizabeth Medical Center
Edgewood, Kentucky, United States, 41017
United States, Louisiana
Tulane Cancer Center at Tulane University Hospital and Clinic
New Orleans, Louisiana, United States, 70112-2699
United States, Maryland
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
United States, Michigan
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States, 48106
United States, Minnesota
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
United States, Missouri
CCOP - Kansas City
Kansas City, Missouri, United States, 64131
United States, Nebraska
Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha
Omaha, Nebraska, United States, 68114-4199
United States, New Jersey
Atlantic City Medical Center - Mainland Division
Pomona, New Jersey, United States, 08240
Community Medical Center
Toms River, New Jersey, United States, 08755
Monmouth Medical Center
Long Branch, New Jersey, United States, 07740-6395
United States, New York
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
East Syracuse, New York, United States, 13057
SUNY Downstate Medical Center
Brooklyn, New York, United States, 11203
United States, North Carolina
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, United States, 27533
United States, Ohio
Licking Memorial Cancer Care Program at Licking Memorial Hospital
Newark, Ohio, United States, 43055-2899
CCOP - Columbus
Columbus, Ohio, United States, 43206
Akron City Hospital at Summa Health System
Akron, Ohio, United States, 44304
Akron General's McDowell Cancer Center
Akron, Ohio, United States, 44302
Adena Regional Medical Center
Chillicothe, Ohio, United States, 45601
CCOP - Dayton
Dayton, Ohio, United States, 45429
CCOP - Toledo Community Hospital
Toledo, Ohio, United States, 43623-3456
Fairfield Medical Center
Lancaster, Ohio, United States, 43130
Grady Memorial Hospital
Delaware, Ohio, United States, 43015
Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University
Cleveland, Ohio, United States, 44106-5065
Mount Carmel West Hospital
Columbus, Ohio, United States, 43222
Strecker Cancer Center at Marietta Memorial Hospital
Marietta, Ohio, United States, 45750-1635
United States, Oregon
CCOP - Columbia River Oncology Program
Portland, Oregon, United States, 97225
United States, Pennsylvania
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212-4772
Lankenau Cancer Center at Lankenau Hospital
Wynnewood, Pennsylvania, United States, 19096
Cancer Center at Paoli Memorial Hospital
Paoli, Pennsylvania, United States, 19301-1792
CCOP - MainLine Health
Wynnewood, Pennsylvania, United States, 19096
Dale and Frances Hughes Cancer Center at Pocono Medical Center
East Stroudsburg, Pennsylvania, United States, 18301
Delaware County Regional Cancer Center at Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, United States, 19026
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States, 19107-5541
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, United States, 19010
Mercy Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15219
Reading Hospital and Medical Center
Reading, Pennsylvania, United States, 19612-6052
St. Luke's Hospital Cancer Center
Bethlehem, Pennsylvania, United States, 18015
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States, 15224
United States, Utah
McKay-Dee Hospital Center
Ogden, Utah, United States, 84403
Dixie Regional Medical Center
Saint George, Utah, United States, 84770
LDS Hospital
Salt Lake City, Utah, United States, 84143
Cottonwood Hospital Medical Center
Murray, Utah, United States, 84107
University of Utah Health Sciences Center
Salt Lake City, Utah, United States, 84132
Utah Valley Regional Medical Center - Provo
Provo, Utah, United States, 84604
United States, Wisconsin
All Saints Cancer Center at All Saints Healthcare
Racine, Wisconsin, United States, 53405
CCOP - Marshfield Clinic Research Foundation
Marshfield, Wisconsin, United States, 54449
Waukesha Memorial Hospital Regional Cancer Center
Waukesha, Wisconsin, United States, 53188
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States, 53226
Veterans Affairs Medical Center - Milwaukee (Zablocki)
Milwaukee, Wisconsin, United States, 53295
Community Memorial Hospital
Menomonee Falls, Wisconsin, United States, 53051

Sponsors and Collaborators

Radiation Therapy Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:

Jaffer A. Ajani, MD

M.D. Anderson Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Ajani JA, Winter K, Komaki R, Kelsen DP, Minsky BD, Liao Z, Bradley J, Fromm M, Hornback D, Willett CG. Phase II Randomized Trial of Two Nonoperative Regimens of Induction Chemotherapy Followed by Chemoradiation in Patients With Localized Carcinoma of the Esophagus: RTOG 0113. J Clin Oncol. 2008 Jun 23; [Epub ahead of print]

Komaki R, Winter K, Ajani J: Non-operative therapy of local-regional carcinoma of the esophagus: a randomized phase II study of two paclitaxel-based chemoradiotherapy regimens (RTOG 0113). [Abstract] The American Radium Society 89th Annual Meeting, May 5-29, 2007, Amsterdam, Netherlands. A-SS-2, 1, 2007.

Komaki R, Winter K, Ajani A, et al.: A randomized phase II study of two paclitaxel-based chemoradiotherapy regimens for patients with the non-operative esophageal carcinoma (RTOG 0113). [Abstract] Int J Radiat Oncol Biol Phys 66 (3 Suppl 1): A-142, S79-80, 2006.

Study ID Numbers:	CDR0000068420, RTOG-0113
Study First Received:	February 2, 2001
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00009880 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage I gastric cancer
stage II gastric cancer
stage III gastric cancer
stage I esophageal cancer
stage II esophageal cancer

stage III esophageal cancer
adenocarcinoma of the stomach
squamous cell carcinoma of the esophagus
adenocarcinoma of the esophagus

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Gastrointestinal Diseases
Antineoplastic Agents
Esophageal Neoplasms
Physiological Effects of Drugs
Stomach Diseases
Neoplasms by Site
Cisplatin
Stomach Neoplasms
Therapeutic Uses
Digestive System Neoplasms

Mitosis Modulators
Antimitotic Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Digestive System Diseases
Radiation-Sensitizing Agents
Paclitaxel
Fluorouracil
Head and Neck Neoplasms
Tubulin Modulators
Gastrointestinal Neoplasms
Esophageal Diseases
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on November 27, 2009